ActiGraph

ACTIGRAPH L.L.C. · Model GT9X · UDI-DI 00853048008015

ISD Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The GT9X is a body worn device that measures and records physical movement associated with daily activity and sleep. The GT9X is intended for use in applications where quantifiable measurement and storage of physical movement is desired.

Recalls

Date	Firm	Reason
2015-04-09	BTE Technologies, Inc.	On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use sc
2013-12-03	MedX Holdings, Inc.	Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.